With a welter of regulatory upgrades in the UAE and Saudi Arabia in recent years, patients in the Middle East’s leading countries now have wider and faster access to cutting-edge biopharmaceutical innovation than ever before. Here, four leading lights in the region’s pharmaceutical industry highlight some of the most important trends at play, how companies are adapting, and what the future might hold.
Significant Regulatory Progress
For Amr Seif, area lead for the Middle East & Africa at Astellas Pharma, “MEA has undergone tremendous positive progress, particularly in Saudi Arabia and the UAE over the past five years.”
He continues, “This progress has been marked by the establishment of regulatory pathways for oncology and other innovative products, as well as policies for pricing such products. In particular, the UAE has implemented fast-track registrations and abridged registrations, which have shortened the time it takes for innovative drugs to be registered. In fact, drugs can now be registered in the UAE just two to three months after they are registered in the US or Europe. This has made the UAE an attractive hub for innovation and has led to a significant influx of multinational pharmaceutical companies. Saudi Arabia has taken a slightly different approach and is pushing for parallel registration, which allows manufacturers to file for registration simultaneously in both Saudi Arabia and the US or Europe. This approach promotes faster access to life-saving therapies for patients.
Drugs can now be registered in the UAE just two to three months after they are registered in the US or Europe
Amr Seif, Astellas
“Another important pillar of the regulatory environment in the MEA region is patent protection and data protection. In 2020, the Ministry of Health & Prevention (MoHaP) in the UAE implemented an eight-year Data Exclusivity Period from the date of marketing approval for innovative pharmaceutical products. This provides multinational pharmaceutical companies with an environment that is conducive to innovation and attracts them to the region.
“The regulatory environment has also been shaped by private-public partnerships that have emerged in the region over the past decade. These partnerships have significantly reduced the number of unilateral decisions that are made without consulting stakeholders and have created an environment in which stakeholders are encouraged to engage in open dialogue with regulatory authorities. This has enabled the pharmaceutical industry to work closely with the Saudi Arabian, UAE, and Egyptian authorities in shaping a healthy regulatory environment. While there are still some grey areas, there has been a significant positive development in the region.”
An Early Access Hotspot
Gilead Sciences, long a global frontrunner in innovative early access solutions for its portfolio of antiviral drugs, is increasingly looking towards the Middle East as an important early access region.
We were able to bring our medicine for the treatment of triple-negative breast cancer to market very early and prior to registration in some cases because the unmet medical need was clearly identified by the authorities
Vítor Papão, Gilead Sciences
Vítor Papão, the company’s general manager for the Middle East & Russia, states that “We see the Middle East as an area where, in several of the markets we cover, speed to market is very high and we can bring medicines quickly to patients. This is especially true when the authorities identify an unmet medical need, such as breast cancer. We were able to bring our medicine for the treatment of triple-negative breast cancer to market very early and prior to registration in some cases because the unmet medical need was clearly identified by the authorities.”
Papão continues, “We have also, since registration, achieved access in several countries in the region and we have launched in several markets. This is a part of the world where we know we can gain access quickly and where governments are keen for there to be fast access. So again, as part of the intent to provide increasingly better care to the citizens in the region, there is an understanding that access to innovation is a critical part of that.”
A Long Road to Travel on Multi-Country Collaboration
However, the cross-border collaboration on regulatory affairs and health technology assessments seen in other jurisdictions looks unlikely to reach the Middle East any time soon.
“I believe that together we are more powerful,” notes Samir Khalil, executive director for industry lobbying group PhRMA in MEA. “As an example of this, we only need to look to Europe, where drug registration and IP are regulated on a continent-wide level. Unfortunately, the Middle East is altogether more fractured, with countries more often looking to work independently.”
Unfortunately, the Middle East is altogether more fractured [than Europe], with countries more often looking to work independently
Samir Khalil, PhRMA MEA
Khalil adds, “A GCC Patent Office was established in Riyadh several years ago, providing important GCC-wide services on IP protection, which I see as the skeleton of our industry. However, this institution was suddenly closed three years ago, and countries moved to a national approach. Discussions are continuing between member countries to determine how the GCC patent office can be helpful for their patent filing and review.”
He does however point out the sizeable progress made on regulatory affairs in the UAE. “We must recognize the incredible efforts made by the authorities at all levels to embrace a public policy environment in favour of innovation and attracting investments,” begins Khalil. “Specifically, regarding the biopharmaceutical sector, we have an overall favourable environment for innovation led by MoHaP which covers the fastest regulatory approval process in MEA, predictable pricing policies, and respect for IP rights, including RDP. The continued partnership and dialogue between the authorities and industry has contributed tremendously to this favourable environment.”
The Need for Speed & Innovative Access Solutions
For locally embedded firms, such as distributor Biologix, the changing regulatory landscape in the Middle East has necessitated internal upgrades.
To be ahead of the game we had to improve our efficiency of regulatory submissions and respond to urgent needs by setting up innovative market access programs and allowing rapid access to the market
Zeina Sfeir Lahoud, Biologix
“Expectations and regulations have evolved dynamically which meant that to be ahead of the game, we had to improve our efficiency of regulatory submissions and respond to urgent needs by setting up innovative market access programs and allowing rapid access to the market,” explains the firm’s General Manager Zeina Sfeir Lahoud. “It is obvious that the life cycle of innovation has been shortened compared to what it used to be 15 years ago. Today, with the drive for innovation, there is rapid competition once the drug hits the market as the window for deploying the assets is shorter.”
A significant regulatory success for Biologix came in the UAE, with the establishment of a first-ever ‘value management agreement’ in July 2021. “It was such a success that today it is being used by MoHaP as a marker of how to set up market access programs for innovative products,” proclaims Zfeir Lahoud. “At the time it was one of the most sophisticated market access programs in the MENA region and took us nearly two years to completely set it up. This has considered a full array of stakeholders and had to clearly define which patients should be included in the program while determining the eligibility criteria.”
